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Ascensia Diabetes Care is a global specialist diabetes care company, dedicated to helping people living with diabetes. Our mission is to empower people living with diabetes through innovative solutions that simplify and improve their lives. We use our innovation and specialist expertise in diabetes to develop high quality solutions and tools that make a positive, daily difference for people.

At Ascensia, our values serve as the bedrock of our organization. They guide our decisions, actions, and interactions, shaping the culture we collectively foster.

Our Values include:

+ Resilient Growth Mindset

+ Executional Excellence

+ Courageous Leadership

+ Inclusive Collaboration

We believe that when we live our values authentically, both individually and as a team, we unlock our true potential and drive sustainable success.

We are seeking a skilled and motivated Quality Assurance Laboratory Technician II - Histochemistry/Chemistry with expertise in Histology and Chemistry to join our Epredia team. As a Quality Assurance Laboratory Technician II - Histochemistry/Chemistry, you will play a critical role in ensuring the quality and accuracy of our products through meticulous analysis, testing, and documentation. Your proficiency in histological techniques and chemical analysis will contribute to maintaining our high standards of product excellence and regulatory compliance.

What you will be doing:

+ Analyze chemical raw material samples.

+ Analyze chemical bulk solution and finished goods samples.

+ Maintain laboratory records (data integrity).

+ Maintain laboratory histology instruments.

+ Maintain a clean working environment.

+ Perform laboratory and manufacturing instrument calibrations

+ Initiate, revise and implement instrument and test method validation.

+ Review and write/revise laboratory SOP’s on a continuous basis.

+ Analysis of customer complaints including written report.

+ Perform product stability testing/studies

+ Complete project work as to support the organization (including sustaining engineering work)

+ Participate in formulation development

+ Participate in review of risk analysis for product development

+ Lead and participate on Practical Process Improvement teams.

+ Responsible for performing tasks to support the quality system and quality policy as directed by QA/RA management.

+ Familiarity with Quality Systems regulations.

Skills you will need:

+ 3+ years of relevant work experience

+ Associates degree

+ Histologist Certification (HT) preferred

+ Experience supporting a manufacturing environment

+ Must be willing to work with and around hazardous chemicals.

+ Experience of working with FDA-regulated products desired (Medical Device/IVD preferred) (pharmaceutical, dietary supplement or food experience is acceptable).

+ Knowledge of ISO13485 / FDA QSR 21 CFR Part 820 / 803 requirements preferred, 21 CFR Part 110, 111 or 211 is acceptable.

+ Must demonstrate strong organizational skills and be able to handle multiple assignments simultaneously

+ Less than 5% travel (US & International)

+ 3+ years laboratory experience in an FDA-regulated laboratory

+ Proficient in MS applications (Excel, Word, Outlook)

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TO ALL RECRUITMENT AGENCIES: Ascensia does not accept unsolicited third-party resumes.

Building an Inclusive Culture: We are a company that brings varying backgrounds, ideas, and points of view to inventing on behalf of all customers. Our diverse perspectives are enriched by many dimensions, including race, ethnicity, gender, age, physical and mental ability, sexual orientation, religious beliefs, culture, language, and education, as well as professional and life experience. We are committed to diversity, equity, and inclusion, and leveraging our unique perspectives to scale our impact and growth.